PHR1283

Supelco

Cefaclor

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Cefaclor monohydrate
Empirical Formula (Hill Notation):
C15H14ClN3O4S · H2O
CAS Number:
Molecular Weight:
385.82
EC Number:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 792
traceable to PhEur C0630000
traceable to USP 1096906

InChI

1S/C15H14ClN3O4S.H2O/c16-8-6-24-14-10(13(21)19(14)11(8)15(22)23)18-12(20)9(17)7-4-2-1-3-5-7;/h1-5,9-10,14H,6,17H2,(H,18,20)(H,22,23);1H2/t9-,10-,14-;/m1./s1

InChI key

WKJGTOYAEQDNIA-IOOZKYRYSA-N

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Cefaclor belongs to the class of second generation semi-synthetic cephalosporin antibiotic drugs that is normally administered orally. With its broad-spectrum antibacterial action, cefaclor is effective against several gram-positive as well as gram-negative bacteria.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Cefaclor may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and biological samples by various chromatography techniques.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3323 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

hazcat

Resp. Sens. 1 - Skin Sens. 1

storage_class_code

13 - Non Combustible Solids

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Rapid and sensitive high-performance liquid chromatographic determination of four cephalosporin antibiotics in pharmaceuticals and body fluids
Samanidou VF, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 788(1), 147-158 (2003)
Determination of process-related impurities and degradation products in cefaclor by high-performance liquid chromatography
Lorenz LJ, et al.
Journal of Chromatographic Science, 30(6), 211-216 (1992)
The use of a monolithic column to improve the simultaneous determination of four cephalosporin antibiotics in pharmaceuticals and body fluids by HPLC after solid phase extraction-a comparison with a conventional reversed-phase silica-based column
Samanidou VF, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 809(1), 175-182 (2004)
Determination of cefaclor in human plasma by a sensitive and specific liquid chromatographic-tandem mass spectrometric method
Chen X, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 784(1), 17-24 (2003)
Simultaneous determination of cefpirome, cefaclor, ceftazidime, and cephradine in pharmaceutical formulations by reversed phase HPLC
Nawaz M, et al.
Acta Chromatographica , 23(2), 205-213 (2011)

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